Using clear aligners to expand the upper dental arch in children with cleft lip and palate
Official title: Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study
Run by Cairo University · NCT06994754 · Data updated 2026-11-12
This study is testing if clear aligners can help expand the upper jaw in children aged 6-8 with cleft lip and palate.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Select) |
| Status | Recruiting |
| Started | April 6, 2025 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT06994754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6-8 years with bilateral cleft lip and palate who have not undergone previous orthodontic treatment.
✕Probably not a fit
Patients with syndromic cleft lip and palate or those taking medications that influence growth may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of clear aligners in expanding the upper dental arch of children aged 6-8 years with cleft lip and palate. Participants will wear a series of aligners, each for 10 days, and attend monthly check-ups to monitor progress. The study aims to determine if these aligners can achieve significant changes in the dental and skeletal structure of the maxilla. After completing the aligner treatment, 3D x-rays and intraoral scans will be conducted to assess the outcomes of the intervention.
Why it matters
Potential benefit: If successful, this approach could improve dental arch morphology and facilitate better surgical outcomes for children with cleft lip and palate.
How similar studies have gone: While the use of clear aligners for orthodontic treatment is well-established, this specific application for maxillary expansion in cleft lip and palate patients is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mixed dentition. * Both males and females. * Bilateral cleft lip and palate. * Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age. * Presence of maxillary constriction that needs maxillary expansion. * Good periodontal health. * No previous orthodontic treatment. Exclusion Criteria: * Syndromic cleft lip and palate patients. * Taking medications that influence growth.
Where it's running
-
Faculty of Dentistry - Cairo University
Cairo, Select, Egypt Recruiting
Study contacts
- Study coordinator: mahmoud Abo-Salem, M.SC
- Email: mahmoud.abdelsalam@dentistry.cu.edu.eg
- Phone: +201112052622
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.